MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PEREIPHERAL DILATATION CATHETER

Model Number 1008189-20

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The other viatrac dilatation catheter referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the moderately calcified, 80% stenosed internal carotid artery. The first 4. 0 x 20 mm viatrac dilatation catheter was advanced to the lesion without issue; however, during the first inflation to 6 atmospheres (atm), leaking was noted. The device was removed. A second 4. 0 x 20 mm viatrac dilatation catheter was advanced to the lesion without issue; however, leaking was also noted when inflated to 6 atm. The device was removed and the procedure was completed using an additional dilatation catheter of the same size. There were no adverse patient effects or clinically significant delay. No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12200080
• Report Number: 2024168-2021-06273
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648056826
• UDI-Public: 08717648056826
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2022
• Device Model Number: 1008189-20
• Device Catalogue Number: 1008189-20
• Device Lot Number: 0120861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial